Pain, Acute Post-OperativeNCT07528482
Effects of Reflexology and Cold Application Before Chest Tube Removal in CABG Patients
A study testing Reflexology and Cryotherapy alone in people with Pain, Acute Post-Operative and Anxiety, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluated the effects of foot reflexology and cold application, administered separately before chest tube removal, on pain, state anxiety, and physiological parameters in patients following coronary artery bypass graft (CABG) surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute Post-Operative, Anxiety, Chest Tube Removal
- What is being tested?
- Reflexology and Cryotherapy alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 4 May 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older Undergoing chest tube removal following first-time coronary artery bypass graft (CABG) surgery No history of previous open-heart surgery No systemic analgesic use within 4 hours before the intervention Able to communicate and oriented Willing to participate voluntarily and able to provide written informed consent Exclusion Criteria
- Hemodynamic instability or use of inotropic medication History of chronic pain History of alcohol or substance abuse or dependence A diagnosed psychiatric disorder that could affect communication or the ability to complete the study scales Foot lesions, neuropathy, peripheral vascular disease, infection, burns, or open wounds that could prevent reflexology Lower-extremity amputation Local infection or an open wound at the chest tube insertion site that could prevent cold application
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital
Ankara, Ankara, 06010
About this study
Official title: The Effects of Foot Reflexology and Cold Application Administered Before Chest Tube Removal Following Coronary Artery Bypass Graft Surgery on Pain, State Anxiety, and Physiological Parameters: A Randomized Controlled Trial
This randomized controlled trial evaluated the effects of foot reflexology and cold application, administered separately before chest tube removal, on pain, state anxiety, and physiological parameters in patients following coronary artery bypass graft (CABG) surgery. A total of 108 patients were assigned to a foot reflexology group, a cold application group, or a control group receiving routine care. Outcomes were assessed before the intervention, immediately before chest tube removal, and 30 minutes after removal. The study compared changes in these outcomes across the three groups.
Read the detailed description
Detailed Description This three-arm, parallel-group randomized controlled trial evaluated the effects of foot reflexology and cold application administered before chest tube removal on pain, state anxiety, and physiological parameters in patients following coronary artery bypass graft (CABG) surgery.
A total of 108 patients were randomized in a 1:1:1 ratio to the foot reflexology, cold application, or control group, with 36 participants in each group. Participants received a single 20-minute session of foot reflexology (10 minutes per foot), a 20-minute cold application using a 13 × 13 cm cold gel pack placed over gauze on the dressing around the chest tube, or a 20-minute rest period with routine clinical care and no additional nonpharmacological intervention, respectively. Chest tube removal was performed using the same standard clinical procedure in all groups.
Data were collected using a Patient Demographic Information Form, the Visual Analog Scale (VAS) for pain, the State-Trait Anxiety Inventory-State subscale (STAI-I), and a Vital Signs Monitoring Form. Pain, state anxiety, systolic and diastolic blood pressure, pulse rate, respiratory rate, and oxygen saturation were assessed at baseline before the intervention (T1), immediately after the intervention and before chest tube removal (T2), and 30 minutes after removal (T3).
The primary outcome was the VAS pain score at T3. Pain and state anxiety were analyzed using mixed-design ANCOVA, with the corresponding baseline score included as a covariate. Physiological parameters were analyzed using a three-group-by-three-time mixed-design ANOVA. The study assessed whether changes in pain, state anxiety, and physiological parameters differed among the three groups over time.
- Being tested
- Reflexology, Cryotherapy alone
- Keywords
- Reflexology, Cold Application, Chest Tube Removal Pain, Non-pharmacological Interventions, Nursing Care
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyBehavioural
A trained researcher will apply foot reflexology for 40 minutes (20 minutes per foot) prior to chest tube removal. The intervention focuses on specific reflex points on the soles, dorsum, and toes of both feet to reduce pain and anxiety
Cryotherapy aloneBehavioural
A 13 cm x 13 cm cold pack, frozen for at least 2 hours at -20°C/-30°C, will be applied to the skin at the chest tube insertion site for 20 minutes before removal. The area will be covered with a gauze pad to prevent direct contact with the skin
| Study group | Role | What they receive |
|---|---|---|
| Reflexology Group | Experimental | Participants in this group received foot reflexology for 20 minutes (10 minutes per foot) before chest tube removal. Receives: Behavioral: Reflexology |
| Cold Application Group | Experimental | Participants in this group received a 20-minute cold application using a 13 × 13 cm cold gel pack wrapped in gauze and placed over the dressing around the chest tube before removal. Receives: Behavioral: Cryotherapy alone |
| Control Group | No intervention | Patients in this group will receive standard clinical care and monitoring, with no additional interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity 30 minutes after chest tube removal
Pain intensity was measured using a 10-cm Visual Analog Scale (VAS), ranging from 0 ("no pain at all") to 10 ("unbearable pain"). Higher scores indicate greater pain intensity.
Measured: 30 minutes after chest tube removal (T3).
Secondary outcomes (6)
State anxiety score
State anxiety was assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-I), a 20-item scale with total scores ranging from 20 to 80. Higher scores indicate greater state anxiety.
Measured: At baseline before the intervention (T1), immediately after the intervention or waiting period and before chest tube removal (T2), and 30 minutes after chest tube removal (T3).
Physiological Parameters (Systolic Blood Pressure)
Systolic blood pressure was measured in mmHg using a standard bedside monitor.
Measured: At baseline before the intervention (T1), immediately after the intervention or waiting period and before chest tube removal (T2), and 30 minutes after chest tube removal (T3).
Physiological Parameters (Diastolic Blood Pressure)
Diastolic blood pressure will be measured in mmHg using a non-invasive blood pressure monitor.
Measured: Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).
Physiological Parameters (Pulse rate)
Heart rate will be measured in beats per minute (bpm) using a pulse oximeter or cardiac monitor.
Measured: Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).
Respiratory Rate
Respiratory rate was monitored using a standard bedside monitor and recorded in breaths per minute.
Measured: At baseline before the intervention (T1), immediately after the 20-minute intervention or waiting period and before chest tube removal (T2), and 30 minutes after chest tube removal (T3).
Oxygen Saturation (SpO2) (%)
Oxygen saturation will be measured as a percentage (%) using a non-invasive pulse oximeter device attached to the patient's finger.
Measured: Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start15 Dec 2025
- Primary completion8 Apr 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Acute Post-OperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a three-arm, randomized, parallel-group controlled trial. Participants were assigned to one of three groups: foot reflexology, cold application, or control (routine clinical care). Outcomes were assessed at baseline, immediately before chest tube removal, and 30 minutes after removal.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neriman Yükseltürk Simşek, Ankara University
- Investigators
- neriman yükseltürk şimşek, assistant prof, Principal investigator, ankara uyasemin özkan, Study chair, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528482
- Sponsor's protocol ID
- 2025/15
- Status last verified
- Oct 2026
- First submitted
- 4 Apr 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy and confidentiality.